making sense of your environmental monitoring data
TRANSCRIPT
Slide 1Data
PDA Midwest Meeting 032510
• Any type of media can be used
• Small size allows easy placement in a variety of locations
• Allows “continuous” monitoring
Standard surface area of 4 sq. in.
(25.8 sq. cm.)
contact of the agar with the surface
that is being sampled.
• Contact plates should have
picked up during sampling
• Contact plates are placed on the surface to be sampled so that media picks up any organisms that are on the surface.
PDA Midwest Meeting 032510
– Quantitative or Qualitative
• Input from the participants was as follows:
• Graphical Representation “A picture is
worth a thousand word.”
• Assures state of control
• How can you manage If you can’t
measure?
• Input from the participants was as follows:
• Hard to see day to day
• Proof of control (GMP)
• To set alert limits
• Help identify process improvements
are effective
• Input from the participants was as follows:
• Because it is required for compliance
• Provides the FDA something to look at to
show control/prevention monitoring
as business needs to maintain control of
critical production areas
PDA Midwest Meeting 032510
• 21 CFR 211.113(b): Firms must follow
appropriate written procedures designed to
prevent microbiological contamination of
• Without tracking and trending it is difficult
to show that procedures for preventing
contamination are effective.
• FDA 483s and warning letters continuously
state issues with review of environmental
monitoring data.
manufacturing facility: We require to see
the data and the analysis of data
generated from this monitoring including
any trending data.
• Manual/Paper
• Excel/Minitab
• MIMS
• EMS
Alert and Action Limit Excursions
by Test Type.
PDA Midwest Meeting 032510
Graph from Excel Spreadsheet
18
Alert and Action Limit Excursions
by Test Type
PDA Midwest Meeting 032510
Trending with Novatek System
PDA Midwest Meeting 032510
Trend line with Novatek System
www.ntint.com Copyright © 2010 Novatek International
• An example of a linear regression showing bacteria found in all Class 10,000 areas grouped by
location description for sampling done 8 days apart.
PDA Midwest Meeting 032510
• Data over time which allows the use of
statistical data to demonstrate deviations
and conformance to established limits.
• Demonstration of product quality
policy
performance.
negative direction (i.e. increase in
bioburden).
than the alert limits.
PDA Midwest Meeting 032510
What is a Trend?
environmental monitoring policy to ensure
consistency.
• Input from the participants was as follows:
• Monthly
• Quarterly
• Annually
• Weekly
in several locations on the same day or
over the course of several days.
• Results that are typically around a known
value but are moving upward.
• Alert or action level counts that are
generated when re-sampling for previous
excursions.
sample type on the same day.
• Three of more consecutive action level
excursions for a sample type in a room
from any sample site on different days.
• Three of more excursions for a sample
type in a room from four consecutive
samplings.
identified.
well as evaluating recurrences of the same
species.
collected each month and look for any
upward slopes of the lines.
• Graph the data with bar graphs and look
for obvious spikes.
9
SP 06 SP 07 SP 08 SP 09 SP 10 SP 11 SP 12 SP 13 SP 14 SP 17 SP 19
SP 20 SP 21 SP 22 SP 23 SP 25 SP 26 SP 27 SP 28 SP 29 SP 30 SP 31
Action Limit=100
Alert Limit=50
1st Quarter, 2011
identified in the facility.
by Genus.
predominant flora are in your facility and
shows you if changes are occurring over
time.
GPR-Spore, 5, 5% GNC, 0, 0%
Profile of Environmental Isolates by Morphology
Room ABC
1 1
0 0 0 00 0 0 0 0 0 0 0
1
2
1
0 0 0 0
Oct-08 Nov-08 Dec-08 Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09
Chronological Incidence
GPR-Spore Mold
3
1
0 0 0 0 0 0 0 0 0
Forehead Left Chest Left Upper Arm Left Lower Arm Left Finger Right Chest Right Upper Arm Right Lower Arm Right Fingers
Alert and Action Limit Excursions
by Personnel Gown Location
Action Alert Alert (Mold)
PDA Midwest Meeting 032510
Personnel and material flow SOPs,
Cleaning SOPs
each room
excursions
• Excursion responses and CAPAs
PDA Midwest Meeting 032510
for each type of monitoring
• Comparison to the same table from the
previous month or year
differences seen.
• Undesirable
• Detectable
stability
challenge organisms, G. sterothermophilus
• Any organism having been determined to
have an adverse effect on product, based
on risk assessment.
• Based on compendial requirements
product
gowning/handwashing
“objectionable” organisms that are
objectionable.
are objectionable in injectable product due
to potential for production of endotoxin.
• Mold is objectionable due to the possibility
of spreading and resistance to certain
sanitizers.
Salmonella, Listeria, E. coli, B. cereus,
Staphylococcus aureus, Clostridium
flags and warrant further investigation and
confirmation.
further investigation and confirmation.
Microbiological Pharmaceutical QC Labs
states, “The significance of
potential hazard to the user”.
PDA Midwest Meeting 032510
natural plant, animal and mineral products
should be tested for Salmonella, oral
liquids for E. coli, topicals for
Pseudomonas aeruginosa and S. aureus
and articles intended for rectal, urethral, or
vaginal administration for yeast and mold”.
PDA Midwest Meeting 032510
widely recognized that Pseudomonas
numbers…”
identification of colonies found during the
Total Plate Count test. Identification should
not be limited to USP indicator organisms. PDA Midwest Meeting 032510
Conclusions
• Management is expected to know what EM
data means, what the issues have been,
what organisms are present in the
environment.
essential to keeping management
219-661-8620
[email protected]
PDA Midwest Meeting 032510
• Any type of media can be used
• Small size allows easy placement in a variety of locations
• Allows “continuous” monitoring
Standard surface area of 4 sq. in.
(25.8 sq. cm.)
contact of the agar with the surface
that is being sampled.
• Contact plates should have
picked up during sampling
• Contact plates are placed on the surface to be sampled so that media picks up any organisms that are on the surface.
PDA Midwest Meeting 032510
– Quantitative or Qualitative
• Input from the participants was as follows:
• Graphical Representation “A picture is
worth a thousand word.”
• Assures state of control
• How can you manage If you can’t
measure?
• Input from the participants was as follows:
• Hard to see day to day
• Proof of control (GMP)
• To set alert limits
• Help identify process improvements
are effective
• Input from the participants was as follows:
• Because it is required for compliance
• Provides the FDA something to look at to
show control/prevention monitoring
as business needs to maintain control of
critical production areas
PDA Midwest Meeting 032510
• 21 CFR 211.113(b): Firms must follow
appropriate written procedures designed to
prevent microbiological contamination of
• Without tracking and trending it is difficult
to show that procedures for preventing
contamination are effective.
• FDA 483s and warning letters continuously
state issues with review of environmental
monitoring data.
manufacturing facility: We require to see
the data and the analysis of data
generated from this monitoring including
any trending data.
• Manual/Paper
• Excel/Minitab
• MIMS
• EMS
Alert and Action Limit Excursions
by Test Type.
PDA Midwest Meeting 032510
Graph from Excel Spreadsheet
18
Alert and Action Limit Excursions
by Test Type
PDA Midwest Meeting 032510
Trending with Novatek System
PDA Midwest Meeting 032510
Trend line with Novatek System
www.ntint.com Copyright © 2010 Novatek International
• An example of a linear regression showing bacteria found in all Class 10,000 areas grouped by
location description for sampling done 8 days apart.
PDA Midwest Meeting 032510
• Data over time which allows the use of
statistical data to demonstrate deviations
and conformance to established limits.
• Demonstration of product quality
policy
performance.
negative direction (i.e. increase in
bioburden).
than the alert limits.
PDA Midwest Meeting 032510
What is a Trend?
environmental monitoring policy to ensure
consistency.
• Input from the participants was as follows:
• Monthly
• Quarterly
• Annually
• Weekly
in several locations on the same day or
over the course of several days.
• Results that are typically around a known
value but are moving upward.
• Alert or action level counts that are
generated when re-sampling for previous
excursions.
sample type on the same day.
• Three of more consecutive action level
excursions for a sample type in a room
from any sample site on different days.
• Three of more excursions for a sample
type in a room from four consecutive
samplings.
identified.
well as evaluating recurrences of the same
species.
collected each month and look for any
upward slopes of the lines.
• Graph the data with bar graphs and look
for obvious spikes.
9
SP 06 SP 07 SP 08 SP 09 SP 10 SP 11 SP 12 SP 13 SP 14 SP 17 SP 19
SP 20 SP 21 SP 22 SP 23 SP 25 SP 26 SP 27 SP 28 SP 29 SP 30 SP 31
Action Limit=100
Alert Limit=50
1st Quarter, 2011
identified in the facility.
by Genus.
predominant flora are in your facility and
shows you if changes are occurring over
time.
GPR-Spore, 5, 5% GNC, 0, 0%
Profile of Environmental Isolates by Morphology
Room ABC
1 1
0 0 0 00 0 0 0 0 0 0 0
1
2
1
0 0 0 0
Oct-08 Nov-08 Dec-08 Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09
Chronological Incidence
GPR-Spore Mold
3
1
0 0 0 0 0 0 0 0 0
Forehead Left Chest Left Upper Arm Left Lower Arm Left Finger Right Chest Right Upper Arm Right Lower Arm Right Fingers
Alert and Action Limit Excursions
by Personnel Gown Location
Action Alert Alert (Mold)
PDA Midwest Meeting 032510
Personnel and material flow SOPs,
Cleaning SOPs
each room
excursions
• Excursion responses and CAPAs
PDA Midwest Meeting 032510
for each type of monitoring
• Comparison to the same table from the
previous month or year
differences seen.
• Undesirable
• Detectable
stability
challenge organisms, G. sterothermophilus
• Any organism having been determined to
have an adverse effect on product, based
on risk assessment.
• Based on compendial requirements
product
gowning/handwashing
“objectionable” organisms that are
objectionable.
are objectionable in injectable product due
to potential for production of endotoxin.
• Mold is objectionable due to the possibility
of spreading and resistance to certain
sanitizers.
Salmonella, Listeria, E. coli, B. cereus,
Staphylococcus aureus, Clostridium
flags and warrant further investigation and
confirmation.
further investigation and confirmation.
Microbiological Pharmaceutical QC Labs
states, “The significance of
potential hazard to the user”.
PDA Midwest Meeting 032510
natural plant, animal and mineral products
should be tested for Salmonella, oral
liquids for E. coli, topicals for
Pseudomonas aeruginosa and S. aureus
and articles intended for rectal, urethral, or
vaginal administration for yeast and mold”.
PDA Midwest Meeting 032510
widely recognized that Pseudomonas
numbers…”
identification of colonies found during the
Total Plate Count test. Identification should
not be limited to USP indicator organisms. PDA Midwest Meeting 032510
Conclusions
• Management is expected to know what EM
data means, what the issues have been,
what organisms are present in the
environment.
essential to keeping management
219-661-8620
[email protected]